A.
Sample submission requirements:
I. Essential
Documents:
a. Forwarding Letter from Drug Regulatory Authority
or any other statutory authority of the country which has been marked to NIB
for testing/evaluation purpose.
b.
Copy
of Import License/Test License issued by Govt. of India
i. Form -11 (Copy of Import License for
Testing purpose)
ii. Form -10 (Copy of Import License for
Commercial purpose)
iii. Form MD-15 (Copy of License to Import Medical Device)
iv. Form MD-17 (License to Import Medical Devices for the purpose of Evaluation)
v. Form MD-13 (License to Manufacture Medical Devices for the purpose of Testing)
c.
Copy
of Manufacturing License Issued by Govt. of India (In case of Indigenous
Product) Form 25/28/29
d.
Certificate
of Analysis from Manufacturer in respect of the lot submitted for evaluation.
e. Batch
Release Certificate (BRC) from Manufacturer/NCA/NCL of the Country of origin
for the lot submitted for evaluation.
f. Pack
insert and label Claim of the Product
II. Product Specific requirements:
a) Blood
Products Lab- Plasma Based products:
1. Batch
Release from the country of origin for imported samples
2. Certification
of analysis with name of pharmacopoeia complied
b) Biochemical kit lab
b1) Blood Glucose Test Strips:
Quantity of Sample:
A total of 1200 test strips for testing by laboratory & 1200 test strips
as retained sample by the SRRD unit.
Sample Accessories required:
(i) Compatible 10 Nos. of Glucometers as a closed system
(ii) Normal Control Solution (3 mL x 3 Vials)
(iii) Pathological Control Solution (3 mL x 3 Vials)
b2.1) Fully automated analyzer based Glucose Reagent- Open Ended
Chemistry:
Quantity of Sample:
500 mL of Glucose reagent (sufficient to perform 1000 tests) for testing
by laboratory & 500 mL of Glucose reagent as retained sample by the SRRD
unit.
Sample Accessories
required:
(i) Calibrator
(ii) Normal Control
(iii) Pathological Control
(iv) Machine protocol
Materials at (i), (ii) and (iii) to be submitted in quantity enough to
last over 25 days of QC protocol execution – keeping in view the shelf
life of the respective preparations.
b2.2) Fully automated analyzer based Glucose Reagent- Closed Chemistry
System:
Quantity of Sample:
Glucose Reagents/ Test Cartridges/ Modules/ Slides/ Cassettes/ Packs/
Bottles/ Dry-chemistry Cards should be in sufficient quantity to be used
for 25 working days for QC protocol execution/ 1000 tests (whichever
applicable), irrespective of number of tests possible from each
unit/pack/cartridge, keeping in view the on-board shelf life of the
respective preparations & 1000 tests to be retained by SRRD unit.
Sample Accessories
required:
(i) Temporary installation of the Automated Analyzer
(ii) ‘Calibrator’ preparation
(iii) ‘Normal’ control preparation
(iv) ‘Pathological’ control preparation
(v) Equipment related consumables- sample cups/ printer paper/
maintenance reagents/ solutions.
(vi) Service/ technological/ training support with respect to the use of
the equipment.
Materials at (ii), (iii), (iv) and (v) to be submitted in quantity
enough to last over 25 days of QC protocol execution – keeping in view
the on-board shelf life of the respective preparations.
b3) Glucometer Device:
Quantity of Sample:
Glucometer Devices 10 Nos. required for testing by laboratory and 2 Nos.
shall be kept for taking care of exigencies as malfunction etc. to be
retained in SRRD Unit.
Sample Accessories required:
(i) Specific Blood Glucose Test Strips as accessory 1200 Strips
(ii) Level 1 (Normal) Control solution 3ml x 3 vials per model
(iii) Level 2 (Pathological) Control Solution 3ml x 3 vials per model.
B.
Testing fee requirements:
Testing Fee Details 
Payment modes:
1. FOR PAYMENT/DEPOSIT
OF TESTING FEE THOUGH BANK TRANSFER
NAME
OF BANK : BANK OF BARODA, SECTOR-29, NOIDA
(U.P.)
NAME
OF ACCOUNT : NATIONAL INSTITUTE OF BIOLOGICALS
S.B.
ACCOUNT : 26290100001774
IFSC
CODE : BARB0NOIDAX
SWIFT
CODE : BARBINBBNOI
MICR
CODE NO. : 110012066
PAN -AAATN5228R
GSTIN -09AAATN5228R1ZX
ST No.-AAATN5228RST001
TIN -09466201769
2. Net banking : http://www.nib.gov.in/testing_fee.html
Note:
a)
TESTING
FEES IS REQUIRED TO BE SUBMITTED IN ADVANCE ALONG WITH THE RESPECTIVE BATCH
SENT TO THE INSTITUTE FOR TESTING
b) Testing
Fees once submitted at NIB for Samples forwarded through Zonal / Sub-zonal/
Port Offices of CDSCO which can be tested at NIB cannot be refunded.
c) Testing
Fees submitted at NIB for Samples which cannot be tested at NIB can be refunded
or adjusted against other samples within a month of submission of testing fee.
d) Testing
Fees submitted Online should also be intimated to the Institute through email
(1) srrd@nib.gov.in (2) sksharma@nib.gov.in
C. Sample forwarded under the Drugs & Cosmetics Act:
Govt. Analysts under schedule C1 as per the Gazette notification are notified
for the below mention class of drugs. Govt_analyst.html
D. Documentation and Archiving:
All
documents and records are kept in compliance to ISO: 17025.
E. Surveillance:
Complete Unit is under CCTV Surveillance
for necessary security and maintenance of samples and records.
F.Customer feedback: is
always acknowledged. Submission of feedback should be marked at srrd@nib.gov.in. Further a
Suggestions / Complaints / Feedback Register has also being placed in the Unit for necessary redressal.
